None listed
Conditions
Brief summary
When chronic kidney disease patients on dialysis have low calcium due to low vitamin D activity, calcitriol is the standard therapy used. However, it is costly and more likely to cause side effects of high calcium and high phosphate. On the other hand, cholecalciferol is cheaper with possibly less side effects on calcium and phosphate. The purpose of this study is to compare cholecalciferol to calcitriol as vitamin D therapy in patients with chronic kidney disease who are on dialysis. We will change study participants who are on calcitriol to cholecalciferol, and examine cholecalciferol’s effectiveness through its effects on blood results over 12 weeks. During recruitment, participants' age, gender, ethnicity, weight and height, smoking status, existing vitamin D therapy, kidney disease, time on dialysis, other medical conditions, dialysate calcium concentration, phosphate binders, and previous blood results will be obtained from them personally or through medical record. Baseline blood tests will be performed to analyze detailed components of the calcium and vitamin D metabolism systems. If they meet the inclusion criteria, their calcitriol therapy will be changed over to cholecalciferol. Further 3 sets of blood tests will be done at 4-week, 8-week, and 12-week period to monitor treatment effects and determine need for therapy adjustment. We would estimate the proportion of patients on maintenance calcitriol who can be changed successfully to cholecalciferol therapy. We hypothesize that the use of cholecalciferol for maintenance therapy in adult chronic kidney disease patients on dialysis is comparable to the use of calcitriol, as shown by successful change from calcitriol to cholecalciferol therapy in a worthwhile proportion of patients.
Interventions
This is a cohort study conducted over 12 weeks at a Regional Renal Centre at Launceston General Hospital and its satellite Kings Meadows Dialysis Unit.
Dialysis dependent stage 5 chronic kidney disease (CKD) patients who have been stable on oral calcitriol therapy for 3 months will be switched over to oral cholecalciferol therapy at the beginning of study period. Conversion of calcitriol to cholecalciferol will be based on the ratio of 0.25 mcg calcitriol to 25 mcg cholecalciferol. If participa
This is a cohort study conducted over 12 weeks at a Regional Renal Centre at Launceston General Hospital and its satellite Kings Meadows Dialysis Unit. Dialysis dependent stage 5 chronic kidney disease (CKD) patients who have been stable on oral calcitriol therapy for 3 months will be switched over to oral cholecalciferol therapy at the beginning of study period. Conversion of calcitriol to cholecalciferol will be based on the ratio of 0.25 mcg calcitriol to 25 mcg cholecalciferol. If participants are already on both pre-existing cholecalciferol and calcitriol, then calcitriol will be ceased followed by increased cholecalciferol dose based on the conversion ratio earlier. Monthly dispensing of cholecalciferol will be performed by Department of Pharmacy at Launceston General Hospital, to ensure compliance. Baseline participant characteristics including age, gender, ethnicity, body mass index (BMI), smoking status, primary kidney disease(s), time on dialysis, medical comorbidities, dialysate calcium concentration, phosphate binder prescriptions, pre-existing vitamin D therapy and previous biochemical results will be collected. Medical records will be assessed if needed for the information. The effects of this new therapy will be studied over the course of 12 weeks, to determine the success or failure of that change in therapy (as defined by ability of cholecalciferol to maintain serum albumin-corrected calcium levels within target range of 2.10 mmol/L to 2.60 mmol/L). Blood specimens will be collected at baseline, 4-week, 8-week and 12-week after patients have been switched to cholecalciferol. Serum calcium, phosphate, intact parathyroid hormone, alkaline phosphatase, and vitamin D (25-hydroxyvitamin D3, 1,25-dihydroxyvitamin D3) will be measured to determine the effects. Cholecalciferol dosage will be reviewed at 4-week interval with the blood tests to determine the need for adjustment by the investigators (Nephrologist and Nephorology Advanced Trainee)
Sponsors
Launceston General Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patients with stage 5 chronic kidney disease who are on haemodialysis or peritoneal dialysis, and - with pre-existing maintenance calcitriol therapy for at least 3 months at time of recruitment, and - have normal serum calcium level at time of recruitment
Exclusion criteria
- Patients younger than 18 years old - Pregnant women - Patients with hypocalcaemia or hypercalcaemia - Patients whose serum 25-hydroxyvitamin D3 level greater than or equal to 75 nmol/L - Patients with hypoparathyroidism or familial hypophosphataemic rickets
Outcome results
None listed